Which term is a written evaluation by the sponsor's auditor of the results of the audit?

Which term is a written evaluation by the sponsor's auditor of the results of the audit?

• A. Audit
• B. Audit Trail
• C. Audit Report
• D. Audit Certificate

Answer: (C)

In GCP, after an audit is completed, the sponsor’s auditor prepares a formal written evaluation of the audit’s findings, conclusions, and recommendations. This document is called an Audit Report. It serves as the official record of what was reviewed, what was found in terms of regulatory compliance and data integrity, and what actions are suggested to address any issues (often a corrective and preventive action plan). The other terms refer to different things: an audit is the activity itself; an audit trail is the chronological record of data changes in the system; an audit certificate is not the written evaluation of the audit results.

In GCP, after an audit is completed, the sponsor’s auditor prepares a formal written evaluation of the audit’s findings, conclusions, and recommendations. This document is called an Audit Report. It serves as the official record of what was reviewed, what was found in terms of regulatory compliance and data integrity, and what actions are suggested to address any issues (often a corrective and preventive action plan). The other terms refer to different things: an audit is the activity itself; an audit trail is the chronological record of data changes in the system; an audit certificate is not the written evaluation of the audit results.